Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03278938

Collaborator

(none)

Enrollment

Location

Arms

42.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.

Condition or Disease	Intervention/Treatment	Phase
Depressive Illness	Drug: bupropion Drug: citalopram	Phase 4

Detailed Description

Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropiontreatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]

Anticipated Study Start Date :

Jun 29, 2012

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bupropion added to citalopram patients who did not remit with citalopram will continue at the same dose and have bupropion added	Drug: bupropion FDA approved drug for treating depression Other Names: Wellbutrin Drug: citalopram FDA approved treatment for depression Other Names: Celexa
Active Comparator: citalopram added to bupropion Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added	Drug: bupropion FDA approved drug for treating depression Other Names: Wellbutrin Drug: citalopram FDA approved treatment for depression Other Names: Celexa

Arm

Intervention/Treatment

Active Comparator: bupropion added to citalopram

patients who did not remit with citalopram will continue at the same dose and have bupropion added

Drug: bupropion

FDA approved drug for treating depression

Other Names:

Wellbutrin

Drug: citalopram

FDA approved treatment for depression

Other Names:

Celexa

Active Comparator: citalopram added to bupropion

Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added

Drug: bupropion

FDA approved drug for treating depression

Other Names:

Wellbutrin

Drug: citalopram

FDA approved treatment for depression

Other Names:

Celexa

Outcome Measures

Primary Outcome Measures

Hamilton Rating Scale [weeks 6]
Decrease in score for Hamilton Rating Scale for Depression, 17-item version

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

non-remission in Protocol #6559R
age 18-66
signs informed consent
physically healthy

Exclusion Criteria:

bipolar disorder
history of psychosis
history of anorexia nervosa or bulimia
history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk